Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study (RDPAF)

September 27, 2022 updated by: Marshall Jacobus Heradien, Pace Clinic

Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study

The autonomic nervous system plays an important role in the precipitation of AF in structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent new-onset AF.

Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and improvement of diastolic dysfunction follow as a consequence of afterload reduction and renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci originate.

Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by reducing afterload. These synergistic mechanisms may prevent new-onset AF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred consenting patients meeting all inclusion criteria will undergo an exercise stress test, 2D and M-Mode echocardiograms and 24-hour ambulatory blood pressure holter monitoring prior to being randomised to receive either renal denervation (RDN) with a Symplicity renal denervation catheter plus medical therapy or medical therapy alone. Coronary angiography with/without coronary revascularisation will be performed as per the treating cardiologist's clinical judgement and a Reveal® holter will be implanted in all patients at the end of the procedure.

Time zero will be defined as starting at three months after the procedure. Follow up visits will be scheduled to scan the holter for the primary end point, i.e. high atrial rates (AF-surrogate defined as: "episodes of atrial rate >190 beats per minute for more than 6 minutes") or new-onset AF. Patients will be followed six monthly for three years.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7505
        • Pace Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have an indication for coronary angiography e.g.
  • Acute coronary syndrome
  • Positive stress ECG: - Defined as ≥1mm ST segment shift (depression or elevation) in ≥2 contiguous leads with/without chest discomfort)
  • Age ≥55 years
  • Office blood pressure ≥160/90mmHg in non-diabetics or ≥150/90mmHg in diabetics
  • Subjects must be on at least 3 anti-hypertensive drugs, including a diuretic agent
  • Sinus rhythm
  • Left ventricular hypertrophy defined on echo as:
  • Estimated LV mass > 255 g or LVMI >131 g/m2 for men
  • Estimated LV mass >193 g or LVMI >113 g/m2for women
  • Left atrial diameter ≥45mm on any echocardiographic window

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 45ml/min/1.73m2
  • Renal artery anatomy unsuitable for RDN
  • Substantial stenotic valvular heart disease
  • Pregnancy or planned pregnancy
  • Thyrotoxicosis
  • Patients needing to undergo coronary artery bypass surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal denervation
Renal denervation: both renal arteries are denervated by applying radio-frequency energy at application points moving in a helical fashion starting in the distal renal artery and moving to the proximal junction with the abdominal aorta.
Device: Renal denervation
In patients randomized to intervention both renal arteries will be treated with radio-frequency energy as per standard Symplicity protocol.In patients randomized to medical-treatment group only, sham renal denervation will be performed by only injecting contrast agent into both renal arteries.
Other Names:
  • Symplicity catheter renal denervation
Drug: Medical therapy
Subjects will continue on their standard medical therapy as prescribed by their treating physician
Other Names:
  • Three or more blood pressure tablets, including a diuretic
Sham Comparator: Medical therapy
This group will not receive renal sympathetic denervation
Drug: Medical therapy
Subjects will continue on their standard medical therapy as prescribed by their treating physician
Other Names:
  • Three or more blood pressure tablets, including a diuretic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation
Time Frame: 3 years
Subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) or atrial fibrillation recorded by implantable loop recorder (Reveal® holter).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of autonomic imbalance
Time Frame: 3 years
Restoration of autonomic imbalance: lowering resting heart rate, prolonging the PR-interval and improving heart rate recovery after exercise.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pace Clinic

Collaborators

University Hospital, Saarland

Investigators

  • Study Director: Paul A Brink, PhD, Tygerberg Hospital and Stellenbosch University
  • Study Director: Michael Bohm, PhD, University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

June 6, 2022

Study Completion (Actual)

June 6, 2022

Study Registration Dates

First Submitted

November 9, 2013

First Submitted That Met QC Criteria

November 16, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDPAF1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Renal denervation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe